Reduced dose of salvage-line regorafenib monotherapy for metastatic colorectal cancer in Japan

Gen Hirano, Akitaka Makiyama, Chinatsu Makiyama, Taito Esaki, Hisanobu Oda, Keita Uchino, Masato Komoda, Risa Tanaka, Yuzo Matsushita, Kenji Mitsugi, Yoshihiro Shibata, Hozumi Kumagai, Shuji Arita, Hiroshi Ariyama, Hitoshi Kusaba, Koichi Akashi, Eishi Baba

Research output: Contribution to journalArticlepeer-review

20 Citations (Scopus)


Background: Salvage-line regorafenib monotherapy exhibited a marked survival benefit for metastatic colorectal cancer (mCRC). However, the toxicity of this regimen has resulted in the clinical use of a reduced dose of regorafenib.

Patients and Methods: Thirty-two Japanese mCRC patients (median age=61 years) who had been treated with regorafenib were retrospectively examined.

Results: Best objective response rate was 0% and stable disease (SD) was 31%. Median progression-free survival was 81 days and median overall survival was 233 days. Adverse events of any grade were observed in all patients: 17 (53%) patients suffered grade 3 or 4 adverse events including fatigue (13%), anorexia (13%), hand-foot skin reaction (22%) and elevations of alanine aminotransferase/aspartate aminotransferase (19%/16%). One patient with grade 5 liver dysfunction was identified (3%). Twenty-nine (91%) patients required treatment dose reduction or a delay in treatment. The relative dose intensity was 59%. Regorafenib treatments were terminated because of disease progression (59%) or adverse events (34%).

Conclusion: Despite a decrease in the intensity of regorafenib treatment, because of severe adverse events, a fairly favorable efficacy was achieved in Japanese patients.

Original languageEnglish
Pages (from-to)371-378
Number of pages8
JournalAnticancer research
Issue number1
Publication statusPublished - Jan 1 2015

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research


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